Tack Optimized Balloon Angioplasty (TOBA) Study

Philips Clinical & Medical Affairs Global138 enrolled

Overview

A multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).

Intact Vascular intends to conduct a prospective, single arm, multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

138

Conditions

Peripheral Vascular Disease

Interventions

Tack-It Endovascular StaplerDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Rutherford clinical category 2, 3 or 4 * ABI less than or equal to 0.90 * Reference vessel diameter is between 2.5mm and 5.5mm * Target lesion has stenosis greater than or equal to 70% or is occluded * Target lesion is less than or equal to 10cm in length Exclusion Criteria: * Previously implanted stent in the ipsilateral superficial femoral or popliteal artery * Target treatment area is severly calcified (e.g. circumferential calcification or calcium plaque visible on plain fluoroscopy that extends far more than 5.0cm continuously)

Locations (1)

Patrick Peeters, MD

Bonheiden, Belgium

Outcomes

Primary Outcomes

Safety

Composite of new-onset major device-related adverse events.

Time frame: 30 days

Data from ClinicalTrials.gov

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